NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Norwegian Institute of Public Health
Conditions: Tuberculosis, Pulmonary
Interventions: SeroSelectTB rapid TB test
Countries: Ethiopia, South Africa, Tanzania
The performance of a new triage test for active tuberculosis (TB), SeroSelectTB, will be qualified in multi-centre randomised controlled trials at health-posts in South Africa, Tanzania and Ethiopia. Cost effectiveness evaluations will be conducted to support a value proposition to stakeholders and regulatory authorities, and to support commercialization requirements. Consenting adults will provide blood and saliva samples for screening by SeroSelectTB, and sputum collected for routine TB diagnosis by the health services. Clinical and sociodemographic information will be collected. A reliable rapid test will make it possible to identify and selectively treat those with active TB at the local healthcare level. The expected impact includes accurate same-day diagnosis of patients with active TB, reduction of diagnostic delay and TB transmission, and diagnostic cost-savings for patients and healthcare systems in high TB-burden countries.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * 18 years of age or older * Informed Consent Form signed * Unwell, suspected to have TB or pneumonia Exclusion Criteria: * Currently receiving TB treatment * On TB treatment past 30 days or more, or last dose less than 1 month before enrolment
- Awasa, Ethiopia
- Cape Town, Western Cape, South Africa
- Moshi, Tanzania